Message #10 From:
NewsBot Date: November 1, 2006 11:19:00 AM
BVTI News Biovest International Launches Breakthrough Cell Culture Instrument
WORCESTER, Mass.--(BUSINESS WIRE)--Biovest International, Inc. (OTCBB:BVTI) announced that it has launched
its breakthrough AutovaxID automated cell culture device for commercial
sale.AutovaxID is a fully automated, reusable instrument that
employs a fully disposable, closed-system cell-growth chamber
incorporating a hollow-fiber cell-growth cartridge. This unique
bioreactor replaces conventional stainless steel, glass, and plastic
cell-growth chambers that require up to ten times as much laboratory
space. Because it is fully enclosed and automated, AutovaxID requires
almost no supervision and is less expensive to operate. AutovaxID is the
most advanced commercial cell culture system enabling scalable,
cost-effective production of cells or cell-derived products, including
monoclonal antibodies, for personalized medicine applications.
AutovaxID is suitable for growing antibody-secreting cell lines,
including hybridomas and Chinese hamster ovary (CHO) cells which are
currently the back bone of commercial therapeutic protein manufacture.
The system operates with both suspension- and attachment-dependent
cells. Potential applications of the AutovaxID include growth and
expansion of a wide array of cell types including patient-specific cells
for emerging cell-based and cell-derived therapies. Biovest’s
most advanced clinical product employing the AutovaxID bioreactor is a
personalized vaccine against non-Hodgkin’s
lymphoma which is currently in Phase III testing. This vaccine is
manufactured in the AutovaxID from individual cancer patients’
immune system cells.
AutovaxID is the first cell culture system that enables production of
personalized cell-based treatments economically and in compliance with
U.S. Food and Drug Administration Good Manufacturing Practices (GMPs).
Biovest expects that additional applications for AutovaxID will be in
the field of cell based therapeutics including the use of stem cells to
treat a cancers as well as age-related and other degenerative diseases.
Dr. Steve Arikian, Chairman and Chief Executive Officer of Biovest
commented, "The AutovaxID is a major advance in cell culture for
production of complex biologics, especially in personalized medicine.
Today, companies working on personalized medicine must invest millions
of dollars in dedicated facilities to produce products for clinical
trials. AutovaxID will provide these firms with a low-cost alternative
to expensive cell culture methods, while affording unprecedented
regulatory compliance and manufacturing versatility.
Biovest has manufactured and distributed patented hollow-fiber
cell-culture technologies for more than 20 years. AutovaxID, which
incorporates hollow-fiber membranes, is the Company's next-generation
bioreactor. By automating production and employing closed-system,
single-use components, AutovaxID minimizes costly and error-prone manual
monitoring and adjustments while reducing the need for large production
facilities. AutovaxID will facilitate the emerging field of personalized
medicine by allowing production of personalized therapeutics in far less
costly facilities while still maintaining sterility and strict
segregation of patient-specific materials.
Dr. Arikian added, "We believe the AutovaxID holds great promise in
research settings as well as GMP production due to the instrument’s
ease of use, robust operation, and high productivity. Our market
research suggests a very robust demand for AutovaxID from university,
biotech, pharmaceutical and diagnostics clients who need to produce gram
quantities of antibodies in a single run."
AutovaxIDs are currently used for producing cells and cell derived
products at the Biovest’s National Cell
culture Center located in Minneapolis. The National Cell Culture Center
has utilized Biovest’s proprietary hollow
fiber cartridge technology for the production of hundreds of cell lines
for biomedical researchers over the past 15 years.
About Biovest International, Inc.
Biovest International, Inc. is a pioneer in the development of advanced
individualized immunotherapies for life-threatening cancers of the blood
system. Biovest is a majority-owned subsidiary of Accentia
Biopharmaceuticals, Inc. (NASDAQ: ABPI), with its remaining shares
publicly traded. Biovest has a foundation in the manufacture of
biologics for research and clinical trials. In addition, Biovest
develops, manufactures and markets patented cell culture systems,
including the innovative AutovaxID™, which is
being developed as an automated vaccine-manufacturing instrument and for
production of cell-based materials and therapeutics. Biovest's therapy
for follicular non-Hodgkin's lymphoma is currently in a Phase 3 pivotal
clinical trial at more than 20 major medical centers throughout the U.S.
For further information, visit the Company Web site at http://www.biovest.com.
Forward-Looking Statements
Statements in this release that are not strictly historical in nature
constitute "forward-looking statements." Such statements include, but
are not limited to, statements about BiovaxID™
and any other statements relating to products, product candidates, and
product development programs. Such statements may include, without
limitation, statements with respect to the Company's plans, objectives,
expectations and intentions and other statements identified by words
such as "may," "could," "would," "should," "believes," "expects,"
"anticipates," "estimates," "intends," "plans" or similar expressions.
Such forward-looking statements involve known and unknown risks,
uncertainties, and other factors that may cause the actual results of
Accentia and/or Biovest to be materially different from historical
results or from any results expressed or implied by such forward-looking
statements. These factors include, but are not limited to, risks and
uncertainties related to the progress, timing, cost, and results of
clinical trials and product development programs; difficulties or delays
in obtaining regulatory approval for product candidates; competition
from other pharmaceutical or biotechnology companies; and the additional
risks discussed in filings with the Securities and Exchange Commission.
All forward looking statements are qualified in their entirety by this
cautionary statement, and neither Accentia nor Biovest undertakes any
obligation to revise or update this news release to reflect events or
circumstances after the date hereof.
